Adoption of array technologies into the clinical laboratory.

Area of Science:

• Biotechnology
• Clinical Diagnostics
• Molecular Biology

Background:

• Array-based methods are crucial for discovering disease biomarkers and enabling multianalyte testing.
• Clinical laboratories are transitioning single-analyte tests to array formats to meet multiplex testing demands.
• Adoption of array technologies presents challenges including evaluation, personnel training, marketing, and reimbursement.

Purpose of the Study:

• To review the suitability of various array platforms for diagnostic testing.
• To discuss applications of liquid-bead arrays in clinical diagnostics.
• To highlight the importance of flexibility and adaptability in array platforms for future diagnostic needs.

Main Methods:

• Review of current array technologies and their applications in clinical diagnostics.
• Discussion of liquid-bead array platforms and their advantages.
• Examination of specific case studies including cystic fibrosis, carrier status assays, and leukemia subtyping.

Main Results:

• Liquid-bead arrays are well-suited for routine clinical diagnostics due to their analyte density, simultaneous decoding/detection, and customization flexibility.
• Array platforms show promise for improving disease staging, risk stratification, and treatment decisions.
• The review covers applications in cystic fibrosis testing, multidisease carrier status assays, and leukemia subtyping.

Conclusions:

• Array-based methods, particularly liquid-bead arrays, are vital for advancing clinical diagnostics and personalized medicine.
• Flexibility and adaptability of array platforms are imperative as biomarker understanding and testing recommendations evolve.
• Future developments in assay formats and quantitation will further integrate array technologies into diagnostic laboratories.